Pivotal Trial of MRI-guided Transurethral Ultrasound Ablation in Men With Localized Prostate Cancer: Three-year Follow-up.

Document Type

Conference Proceeding

Publication Date

9-2021

Publication Title

Journal of Urology

Abstract

INTRODUCTION AND OBJECTIVE:

MRI-guided transurethral ultrasound ablation (TULSA) is a minimally-invasive procedure for prostate ablation. We report three-year outcomes from the pivotal TULSA-PRO Ablation Clinical Trial (TACT).

METHODS:

The study enrolled 115 men with organ-confined prostate cancer (≤T2b, PSA ≤15 ng/ml, Grade Group 1-2) across 13 centers. Treatment was whole-gland ablation with sparing of the urethra and urinary sphincter. Primary endpoints were safety and PSA reduction at one year. Secondary endpoints included one-year prostate volume reduction, mpMRI, and 10-core biopsy. We report adverse events, quality of life (IPSS, IIEF, EPIC), and PSA for men who are salvage-free and have completed three-year follow-up.

RESULTS:

Median (IQR) baseline age was 65 (59-69) years, median PSA 6.3 (4.6-7.9) ng/ml, with Grade Group ≥2 disease in 72/115 men (63%, 69 GG2, 3 GG3). Targeted prostate volumes of 40 (32-50) cc were ablated in 51 (39-66) min, with 98% thermal coverage and ±1.4 mm spatial precision on MRI thermometry. Grade 3 adverse events in 9 (8%) men included GU infection, stricture, retention, urethral calculus and pain, and urinoma, all resolved before one year. There were no rectal injuries or Grade ≥4 events. By three years, 15 men (13%) underwent salvage treatment. At one year MRI and biopsy, median prostate volume decreased from 37 to 3 cc, GG2 disease was eliminated in 54/68 (79%) men, and 72/111 (65%) had no evidence of any cancer. Median PSA decreased 95% to a nadir of 0.26 ng/mL, stable from 0.53 ng/mL at one year to 0.70 ng/ml (n=56) at three years. Median IPSS decreased from 7 at baseline to 4 (n=61) by three years. Moderate urinary incontinence (Grade 2, pads) in three men (2.6%) at one year persisted to three years in one patient (<1%); there was no new incontinence past one year. The rate of moderate erectile dysfunction (Grade 2, responding to medication) was 23% at one year and 24% at three years. Median change in IIEF-5 was -2 from baseline to one year, and zero from one to three years (n=61). In men with three-year follow-up who were potent at baseline, erections sufficient for penetration (IIEF Q2 ≥2) were maintained by 36/50 (72%) and 40/50 (80%) at one and three years.

CONCLUSIONS:

With three-year follow-up, the TACT pivotal study of MRI-guided transurethral ultrasound ablation (TULSA) in men with localized prostate cancer showed effective disease control with low toxicity and stable quality of life.

Volume

206

Issue

suppl 3

First Page

e814

Comments

Annual Meeting of the American Urological Association, Virtual, September 10-13, 2021.

DOI

10.1097/JU.0000000000002067.03

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